Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest (OHCA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No use of antibiotics, with antibiotics treatment.
- Who it may be relevant to
- Registry conditions: Infection, Bacterial, Out-Of-Hospital Cardiac Arrest. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Qatar
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Specific Aim : The specific aim is to conduct a randomized prospective clinical trial to determine whether no antibiotics in OHCA patients in the ED with very low likelihood of infection is non-inferior to early antibiotic treatment. Hypothesis a: 28-day all-cause mortality will be non-inferior in OHCA patients with very low likelihood of infection who do not receive antibiotic therapy compared with those who receive early antibiotic therapy Hypothesis b: There will be no difference in subsequent incidence of proven infections in the no antibiotics vs, early antibiotics groups Hypothesis c: There will be no difference in the length of ICU stay and overall hospital stay in the early antibiotics vs. no antibiotics groups
Detailed description
As above
Interventions
- Other No use of antibiotics
Subjects will be randomized into antibiotics and no antibiotics groups based on inclusion and exclusion criteria - Other with antibiotics treatment
with antibiotics treatment
Primary outcome measures
- 28-day all-cause mortality. likelihood of infection whether they receive early antibiotic therapy or not. [Time frame: 28-day]
Eligibility criteria
Inclusion criteria
- ● Adults aged >18 years, presenting to HGH ED after out-of-hospital cardiac arrest
- Patients with low likelihood of infection as per the definitions provided above
- Ability to obtain informed consent from the subjects or their next of kin/family member/legal surrogate in case of incapacitation due to sedation, mechanical ventilation, etc. In case the next of kin is not available, an independent physician who is not a part of the investigative team will complete and sign the checklist as per HMC Policy "RES 11026\_Appendix 6.5". (see section 4.1.3 for details) A member of the investigative team and a witness will also sign this form before the potential subject is enrolled in the study.
Exclusion criteria
- Patients who have clear evidence of infection, as defined by criteria for the study.
- Patients who have received antibiotics within the last 1 week prior to admission.
- Patients with malignancy, except those who have been cured or in complete remission.
- Females with known pregnancy.
- Known immunocompromised states (including HIV/AIDS, transplant recipients on immunosuppressant drugs, long-term \[> 3 weeks of prednisone >5mg/day equivalent\] steroid therapy).
- Patients on immunologic disease modifying agents (commonly known as "biologics")
- Patients considered "brain-dead" or "vegetative state"
- Patients transferred from another hospital, long term care facility or institution
- Neutropenia (total WBC <1,500/mm3 or absolute neutrophil count of <1,000/mm3)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Qatar · 1 center
- Hamad Medical Corporation — Doha
Identifiers
NCT: NCT05914779 · IRGC-05-SI-18-356